antiquity
01-23-2003, 01:54 PM
US Regulators Warn OxyContin Maker Over Ads
January 23, 2003 08:18:29 AM PST, Reuters
Two advertisements in a medical journal for the painkiller OxyContin failed to properly warn about the drug's safety risks and potential for abuse, US regulators said in a letter released on Wednesday.
The ads, which appeared last fall in the Journal of the American Medical Association ( news - web sites), also suggested broader use of the prescription drug than what is approved, the Food and Drug Administration ( news - web sites) said in a warning letter.
The drug's maker, privately held Purdue Pharma, said the letter was the result of "an honest misunderstanding" regarding the presentation of safety information. The company said it was committed to providing doctors with full information about the drug's risks and benefits and had discontinued the ads.
OxyContin, when taken properly, is formulated to relieve pain over 12 hours. But drug-abuse experts say abusers crush the pill to snort or inject it and get a quick high. Taking broken, chewed or crushed tablets can lead to absorption of a potentially fatal dose, according to a warning on the drug's label.
The FDA letter said Purdue Pharma's ads "grossly overstate" the drug's safety. They "fail to disclose in the body of the advertisements serious and significant risks associated with the use of OxyContin and important limitations on the indicated use," the letter said.
"The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health," the letter said.
Purdue Pharma said in a statement there was an "honest misunderstanding, which we regret" about the placement of safety information in the promotions. The front page of each ad "prominently referenced" a boxed warning about the drug, and the warning was printed in its entirety on a subsequent page, the company said.
The company also said the ads "do not recommend usage of OxyContin beyond the FDA-approved label indication."
Purdue Pharma said it was committed to providing physicians "with full
information on the risks, benefits and potential side effects of prescribing pain medications such as OxyContin."
The company said it had run ads featuring only the boxed warning in medical journals 140 times between January and May 2002 and had trained sales representatives to discuss the warning with physicians.
The FDA letter asked the company to immediately stop disseminating the ads or any materials with similar violations and to provide a plan for circulating accurate information to audiences that may have seen the ads in question.
A response is due by Friday.
http://health.yahoo.com/search/healthnews?lb=s&p=id%3A34582
January 23, 2003 08:18:29 AM PST, Reuters
Two advertisements in a medical journal for the painkiller OxyContin failed to properly warn about the drug's safety risks and potential for abuse, US regulators said in a letter released on Wednesday.
The ads, which appeared last fall in the Journal of the American Medical Association ( news - web sites), also suggested broader use of the prescription drug than what is approved, the Food and Drug Administration ( news - web sites) said in a warning letter.
The drug's maker, privately held Purdue Pharma, said the letter was the result of "an honest misunderstanding" regarding the presentation of safety information. The company said it was committed to providing doctors with full information about the drug's risks and benefits and had discontinued the ads.
OxyContin, when taken properly, is formulated to relieve pain over 12 hours. But drug-abuse experts say abusers crush the pill to snort or inject it and get a quick high. Taking broken, chewed or crushed tablets can lead to absorption of a potentially fatal dose, according to a warning on the drug's label.
The FDA letter said Purdue Pharma's ads "grossly overstate" the drug's safety. They "fail to disclose in the body of the advertisements serious and significant risks associated with the use of OxyContin and important limitations on the indicated use," the letter said.
"The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health," the letter said.
Purdue Pharma said in a statement there was an "honest misunderstanding, which we regret" about the placement of safety information in the promotions. The front page of each ad "prominently referenced" a boxed warning about the drug, and the warning was printed in its entirety on a subsequent page, the company said.
The company also said the ads "do not recommend usage of OxyContin beyond the FDA-approved label indication."
Purdue Pharma said it was committed to providing physicians "with full
information on the risks, benefits and potential side effects of prescribing pain medications such as OxyContin."
The company said it had run ads featuring only the boxed warning in medical journals 140 times between January and May 2002 and had trained sales representatives to discuss the warning with physicians.
The FDA letter asked the company to immediately stop disseminating the ads or any materials with similar violations and to provide a plan for circulating accurate information to audiences that may have seen the ads in question.
A response is due by Friday.
http://health.yahoo.com/search/healthnews?lb=s&p=id%3A34582